The Union health ministry will soon amend provisions for grant of Form 29 to boost research and development (R&D) in the area of pharmaceuticals country. Form 29 is a license to manufacture drugs for the purpose of examination, testing and analysis.
The ministry’s decision in this regard is based on recommendations from the industry as well as the Drugs Technical Advisory Board (DTAB).
As of today, New Drugs and Clinical Trials (NDCT) Rules, 2019 stipulates that permission in Form CT-11/14/15 needs to be obtained for grant of Form 29.
Industry has long been suggesting that in line with international practices, requirements of Form CT-11/14/15 and Form 29 should be abolished. Alternatively, only one requirement i.e., Form-29 should be mandated.
Accordingly, the necessary amendments should be made in the Drugs and Cosmetics (D&C) Rules, 1945 and the NDCT Rules, 2019.
DTAB has considered the proposal to examine the requirement of Form CT-11/14/15 and Form 29 as prescribed in the NDCT Rules, 2019 and D&C Rules, 1945 respectively.
DTAB was apprised that, earlier, as per D&C Rules, only Form 29, no objection certificate (NOC), irrespective of BE and Non-BE purpose, was required to be obtained for grant of Form 29.
Industry representatives have been raising the concern stating that India is having such stringent and excessive requirements for developing product for examination, test, analysis, clinical trials (CT) or bio-equivalence (BE) study. Because of these excessive requirements, industries are facing difficulties in registration of their product in India as well as globally.
DTAB deliberated the issue and recommended that provision may be made for notification of information by the applicant relating to manufacture of new drug for test and analysis under Form CT-10/12/13 except for batches manufactured for clinical trial or BA/BE studies.
It further recommended that with regards to grant of license in Form-29, timeline may be specified as seven working days for its issuance by licensing authority, failing which it shall be considered deemed approved. In both the cases, however, the facility shall remain open for regulatory inspections.
Accordingly, the necessary amendments should be made in the D&C Rules, 1945 and the NDCT Rules, 2019, DTAB recommended.
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